Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder (NBIRR-1)

• ClinicalTrials.gov Identifier: NCT01105962
• Recruitment Status: Terminated
• First Posted: April 19, 2010
• Last Update Posted: September 20, 2016
• Sponsor: International Hyperbaric Medical Foundation
• Information provided by (Responsible Party): International Hyperbaric Medical Foundation

Study Description

Brief Summary:

This is an observational research study whose purposes are to see:

1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).
2. if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health.
3. determine the long-term outcome of the treatment.
4. confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies

Condition or disease
Traumatic Brain Injury; Post-traumatic Stress Disorder

Study Design

• Study Type: Observational
• Actual Enrollment: 133 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Multicenter Observational Study of Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post-Concussion Syndrome (PCS) and/or TBI/Post-Traumatic Stress Disorder (PTSD)
• Study Start Date: May 2010
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Cognitive Function [ Time Frame: 2-6mo then every 6 months for 2yrs ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

One thousand subjects will be recruited. Subjects will be 18-65 years old and have been diagnosed with mild or moderate (but not severe) TBI or TBI/PTSD or PTSD by either the military (any etiology) or civilian neurologists or neuropsychologists. This diagnosis will especially include war veterans who have had a significant decrease in their neuropsychological test scores.

There will be no gender restriction. However, it is anticipated that the cohort will consist mostly of males, due to the nature of the injury. There will be no race or ethnicity restriction.

All subjects will be legally capable of consenting. No subjects who need 3rd party consent will be enrolled in the NBIRR study.

Military - Unless specifically approved by a military site IRB, active duty participants will have to voluntarily contact NBIRR participating sites or respond to a recruitment outreach outside of the command.

Criteria

Inclusion Criteria:

1. Any 18-65 year-old patient with mild-moderate TBI or PTSD. (If a military injury, subject may be active duty or a veteran. If active duty, participants will have to voluntarily contact NBIRR.)
2. Have demonstrated a >20% decrement (compared to pre-deployment baseline) in ANAM composite score or specific sub-score with regard to "simple reaction time" and/or "procedural reaction time".
3. Have a diagnosis of TBI, chronic TBI/PCS or TBI/PCS/PTSD or PTSD made by a military (military etiology of blast injury) or civilian specialist.
4. Negative pregnancy test in females.
5. Less than 90% on the Percent Back to Normal Rating Scale. (If patient is considered 100% normal before TBI, patient should be less than 90% normal for entry into the study).

Exclusion Criteria:

1. Pulmonary disease that precludes HBOT (e.g., asthma unresponsive to medication, bullous emphysema).
2. Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
3. Severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for MRI or who cannot go in elevators).
4. Pregnancy.
5. Other pre-TBI neurological diagnoses.(seizure disorders, multiple sclerosis, Parkinson's, Lyme, etc.)
6. Participation in another experimental trial with active intervention.
7. High probability of inability to complete the experimental protocol (e.g. terminal condition).
8. Past or current history of mental retardation unless diagnosed post TBI (baseline IQ ≤ 70).
9. Pre- or post-TBI history of systemic illness with impact on central nervous system. (Principal Investigator in consultation with study sponsor Medical Officer will make the ultimate decision).
10. Any pre-existing chronic infection not related to battlefield injuries or government service.

Contacts and Locations

Locations

United States, California

San Francisco Institute for Hyperbaric Medicine

San Francisco, California, United States, 94107

United States, Colorado

Rocky Mountain Hyperbaric Institute

Boulder, Colorado, United States, 80301

United States, Florida

Hyperbaric Services of the Palm Beaches

Del Ray Beach, Florida, United States, 33484

Hyperbaric Medicine Inc. of Florida

Ft. Walton Beach, Florida, United States, 32547

United States, Idaho

Idaho Wound Care & Hyperbaric Medicine

Pocatello, Idaho, United States, 83201

United States, Minnesota

Lifeforce Therapies

Plymouth, Minnesota, United States, 55447

United States, Nevada

Hyperbaric Institute of Nevada and Clinical Neurology Specialists

Henderson, Nevada, United States, 89012

United States, Ohio

Alliance Community Hospital Wound Care and Hyperbaric Department

Alliance, Ohio, United States, 44601

United States, Virginia

HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia

Reston, Virginia, United States, 20190

United States, Wisconsin

Fox Valley Wellness Center

Fond du Lac, Wisconsin, United States, 54935

Sponsors and Collaborators

International Hyperbaric Medical Foundation

Investigators

• Study Director: B Robert Mozayeni, MD; International Hyperbaric Medical Foundation

More Information

Additional Information:

National Brain Injury Rescue and Rehabilitation Project 

• Responsible Party: International Hyperbaric Medical Foundation
• ClinicalTrials.gov Identifier: NCT01105962
• Other Study ID Numbers: NBIRR-01
• First Posted: April 19, 2010
• Last Update Posted: September 20, 2016
• Last Verified: September 2016

Keywords provided by International Hyperbaric Medical Foundation:

traumatic; brain; injury; post-traumatic; stress; hyperbaric; oxygen; HBOT; TBI; PTSD

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Mental Disorders